CN1785419A - Agastachel patchouli qi-righting fast dispersion solid preparation and its preparation method - Google Patents
Agastachel patchouli qi-righting fast dispersion solid preparation and its preparation method Download PDFInfo
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Abstract
A fast dispersing solid Chinese medicine for restoring health is prepared from 13 Chinese-medicinal materials including cablin potchouli herb, perilla leaf, tangerine peel, liquorice root, etc through crushing or extracting, superfine pulverizing, and mixing with disintegrant, adhesive, suspending aid, flowing aid, flavouring and coloring agent.
Description
Technical field:
The present invention relates to a kind of Chinese medicine fast dispersion solid medicine and preparation method thereof, particularly the fast dispersion solid medicine of ageratum belongs to field of traditional Chinese.
Technical background:
Ageratum Chinese patent medicine on the market, comprise HUOXIANG ZHENGQI RUANJIAONANG, HUOXIANG ZHENGQI WAN, JIAWEI HUOXIANG ZHENGQI WAN, HUOXIANG ZHENGQI SHUI, ageratum mixture, HUOXIANGZHENGQI KOUFUYE, their basic prescription comes from Song " peaceful Huimin drawn game agent side ", form by medicines such as Herba Pogostemonis, Folium Perillae, Poria, the Radixs Angelicae Dahuricae, the removing dampness of inducing sweat is arranged, regulate the flow of vital energy and in merit, be used for treating diseases such as fever with chills, headache, stomachache, fullness in the chest are felt sick, vomiting and diarrhoea more, be summer and autumn Chinese patent medicines commonly used.As clinical Chinese patent medicine commonly used, it uses history to exceed thousand, is described as the wet disease " panacea " of classics recipe by ancient Chinese medicine doctor.The modern clinical indications such as acute gastroenteritis, gastric flu, dysentery and gastric motility disorder dyspepsia that are usually used in treating, the uncomfortable symptom that travel outdoors, being not acclimatized, air conditioning disease and diet are become estranged etc. caused also has better curative effect.
Traditional pharmaceutical preparation is " huoxiang zhengqi powder " (decoction made from powder), change " HUOXIANG ZHENGQI WAN " in early days into, the existing dosage forms such as HUOXIANG ZHENGQI WAN (concentrated pill), JIAWEI HUOXIANG ZHENGQI WAN, JIAWEI HUOXIANG ZHENGQI WAN (honeyed pill), HUOXIANG ZHENGQI SHUI, ageratum mixture, HUOXIANGZHENGQI KOUFUYE, HUOXIANG ZHENGQI RUANJIAONANG of again pill being changed system into.At present " that records in Chinese pharmacopoeia and " the Ministry of Public Health standard for traditional Chinese medicines " has a following HUOXIANG ZHENGQI ZHIJI:
(1) HUOXIANG ZHENGQI WAN (concentrated pill) (" Ministry of Public Health standard for traditional Chinese medicines ", standard No. WS3-B-1465-93)
[prescription and method for making] Herba Pogostemonis 150g, Folium Perillae 50g, Radix Angelicae Dahuricae 50g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 100g, Pericarpium Citri Reticulatae 100g, Rhizoma Pinelliae (processed) 100g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 100g, Poria 50g, Radix Platycodonis 100g, Radix Glycyrrhizae 100g, Pericarpium Arecae 50g, Fructus Jujubae 25g, Rhizoma Zingiberis Recens 15g, more than 13 the flavor, get Herba Pogostemonis, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Magnoliae Officinalis, Rhizoma Zingiberis Recens is a solvent with 70% ethanol, the Rhizoma Pinelliae is a solvent with 45% ethanol, according to " the percolation dipping under 2000 editions fluid extracts of Chinese pharmacopoeia and the extractum item carried out percolation after 24 hours, collected the liquid of filtering, reclaim ethanol, it is the thick paste of 1.30～1.35 (20 ℃) that concentrating under reduced pressure becomes relative density; Get Folium Perillae and extract volatile oil, residue and Pericarpium Arecae, Fructus Jujubae decoct with water secondary, and 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into the thick paste that relative density is 1.30～1.35 (20 ℃); Get the Radix Angelicae Dahuricae, Poria, balloonflower powder and be broken into fine powder; Radix Glycyrrhizae partly is ground into fine powder, and part is made extractum; With above-mentioned each cream, powder mixing, add Folium Perillae volatile oil, mixing, pill, drying, polishing, promptly.
[usage and consumption] is oral, one time 8 ball, 3 times on the one.
(2) JIAWEI HUOXIANG ZHENGQI WAN (" Ministry of Public Health standard for traditional Chinese medicines ", WS3-B-3794-98)
Herba Pogostemonis 150g, Folium Perillae 50g, Radix Angelicae Dahuricae 50g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 100g, Pericarpium Citri Reticulatae 100g, Rhizoma Pinelliae (processed) 100g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 100g, Poria 50g, Radix Platycodonis 100g, Radix Glycyrrhizae 100g, Pericarpium Arecae 50g, Fructus Jujubae 25g, Rhizoma Zingiberis Recens 15g, more than 13 the flavor, be ground into fine powder, sieve mixing.Every 100g powder adds refined honey 50～60g and an amount of water, general ball, and drying is made water-honeyed pill; Or add refined honey 150～170g and make big honeyed pills, promptly.
[usage and consumption] is oral, 5～10g of water-honeyed pill, one time 1～2 ball of big honeyed pills, 2～3 times on the one.
(3) JIAWEI HUOXIANG ZHENGQI WAN (honeyed pill) (" Ministry of Public Health standard for traditional Chinese medicines ", WS3-B-3794-98)
[prescription and method for making] Herba Pogostemonis 150g, Folium Perillae 50g, Radix Angelicae Dahuricae 50g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 100g, Pericarpium Citri Reticulatae 100g, Rhizoma Pinelliae (processed) 100g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 100g, Poria 50g, Radix Platycodonis 100g, Radix Glycyrrhizae 100g, Pericarpium Arecae 50g, big 25g, Rhizoma Zingiberis Recens 15g, more than 13 the flavor, be ground into fine powder, sieve mixing.Every 100g powder adds refined honey 50～60g and an amount of water, general ball, and drying is made water-honeyed pill; Or add refined honey 150～170g and make big honeyed pills, promptly.
[usage and consumption] is oral, 5～10g of water-honeyed pill, one time 1～2 ball of big honeyed pills, 2～3 times on the one.
(4) HUOXIANG ZHENGQI SHUI (" Chinese pharmacopoeia 2000 version one one)
[prescription and method for making] Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml, more than ten the flavor, Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae are respectively according to the percolation under pharmacopeia fluid extract and the extractum item, make solvent with 60% ethanol, flood and carry out percolation after 24 hours, each collects the liquid 400ml that just filters first three kind, the first liquid 500ml that filters of a kind of collection in back, standby, continue percolation, collect the continuous liquid of filtering, incorporate in the liquid of just filtering after concentrating.After Poria adds water boil, 80 ℃ of warm macerating secondaries, 3 hours for the first time, 2 hours for the second time, extracting juice; The Rhizoma Pinelliae cold water soak was changed water once in per 8 hours, and bubble is to the saturating heart, and other adds Rhizoma Zingiberis 13.5g, decocts with water secondary, and 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocts with water 3 hours, and Radix Glycyrrhizae extractum is smashed the back decocting in water and melted; Merge above-mentioned decocting liquid, filter, filtrate is concentrated in right amount.Patchouli oil, Folium perillae acutae oil dissolve in right amount with ethanol.Merge above solution, mixing is adjusted ethanol content in right amount with ethanol and water, and is made full dose become 2050ml, leaves standstill, filter, and fill, promptly.
(5) the ageratum mixture (" Ministry of Public Health standard for traditional Chinese medicines ", WS3-B-1466-93)
[prescription and method for making] Herba Pogostemonis 150g, Folium Perillae 50g, Radix Angelicae Dahuricae 50g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 100g, Pericarpium Citri Reticulatae 100g, the Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 100g, Poria 50g, Radix Platycodonis 100g, Radix Glycyrrhizae 100g, Pericarpium Arecae 50g, Fructus Jujubae 25g, Rhizoma Zingiberis Recens 15g, more than 13 flavors, the Rhizoma Pinelliae, the Rhizoma Atractylodis Macrocephalae are according to the percolation (17 pages of appendix) under fluid extract and the extractum item, make solvent with 70% ethanol, carry out percolation, reclaim ethanol; Herba Pogostemonis, the Rhizoma Atractylodis Macrocephalae, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae and Folium Perillae distillating extracting oil; Six-elements such as medicinal residues and all the other Poria decoct with water three times, and collecting decoction filters, and filtrate is concentrated in right amount, merge with the liquid of filtering, and leave standstill, and filter, and reconcentration is to about 1000ml, and the adding antiseptic is an amount of, put coldly, add above-mentioned volatile oil, add water to 1000ml, stir evenly, promptly.
(6) HUOXIANGZHENGQI KOUFUYE (" Chinese pharmacopoeia 2005 version one one)
[prescription and method for making] Rhizoma Atractylodis 80g, Pericarpium Citri Reticulatae 80g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 80g, Radix Angelicae Dahuricae 120g, Poria 120g, Pericarpium Arecae 120g, Rhizoma Pinelliae 120g, Radix Glycyrrhizae extractum 10g, patchouli oil 0.8ml, Folium perillae acutae oil 0.4ml, more than ten the flavor, Cortex Magnoliae Officinalis was made the solvent reflux 1 hour with 60% ethanol, and it is standby to get ethanol liquid; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae add the water distillation, collect distillate, and distillation back water liquid filters, and is standby; Pericarpium Arecae decocts with water 2 times, filters; After Poria added water boil, 80 ℃ of warm macerating secondaries filtered; To the saturating heart, other adds Rhizoma Zingiberis 6.8g to Rhizoma Pinelliae, decocts with water 2 times with blister.Merge above-mentioned filtrate, being concentrated into relative density is 1.10～1.20 (50 ℃), adds Radix Glycyrrhizae extractum, mixing, add 2 times of amount ethanol and make precipitation, filter, filtrate and Cortex Magnoliae Officinalis ethanol extract merge, and reclaim ethanol, add patchouli oil, Folium perillae acutae oil then, mixing, adjusted volume and pH value, promptly.
(7) HUOXIANG ZHENGQI RUANJIAONANG (" Chinese pharmacopoeia 2005 version one one)
[prescription and method for making] Rhizoma Atractylodis 195g, Pericarpium Citri Reticulatae 195g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 195g, Radix Angelicae Dahuricae 293g, Poria 293g, Pericarpium Arecae 293g, Rhizoma Pinelliae 195g, Radix Glycyrrhizae extractum 24.4g, patchouli oil 1.95ml, Folium perillae acutae oil 0.98ml, more than ten the flavor, ethanol liquid is got in Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Angelicae Dahuricae ethanol extraction 2 times, and it is standby to be concentrated into clear paste; Poria, Pericarpium Arecae decoct with water 2 times, filter; The Rhizoma Pinelliae cold water soak was changed water once in per 8 hours, and bubble is to the saturating heart, and other adds 16.5 parts of Rhizoma Zingiberiss, decocts with water 2 times, filters.Merge above-mentioned filtrate, concentrate the back precipitate with ethanol, get supernatant concentration to clear paste; Add Radix Glycyrrhizae extractum, mixing adds patchouli oil, Folium perillae acutae oil mixing, the preparation soft capsule, promptly.
In the above preparation, (1), (2), (3) are solid preparation, and dosage form is pill, prepares with traditional method; Oral, one time dose is bigger, uses inconvenience, has brought trouble for the patient of old, children and dysphagia; (4), (5), (6) are liquid dosage form, though taking convenience carries inconvenience, taste is bad when taking; (7) be soft capsule, but still have the characteristics of traditional solid dosage forms on using.
Superfine communication technique is meant the material particles more than 3 millimeters is crushed to process below 100 microns.Researcher thinks, because granular size develops to miniaturization, thus can cause surface area and porosity to increase very significantly, so the micronizing body has unique physics and chemical property.For example, have fine solubility, dispersibility, adsorptivity, chemism etc., so application is very extensive.Studies show that all available micronizing apparatus processing of raw material such as many edible animals and plants, microorganism, medicine become superfine powder, the medicine of miniaturization has very strong surface adsorption power and affinity, therefore, has good dispersibility and dissolubility, assimilates easily.
Dispersible preparation is that a kind of water that do not need in the oral cavity can disintegrate or dissolved preparation fast.Requirement has: 1. in the oral cavity rapidly disintegrate, no grittiness, good mouthfeel, swallow easily, to the oral mucosa nonirritant.Should stipulate under the character item in the quality standard: disintegrate rapidly, no grittiness, good mouthfeel in the oral cavity; 2. set up suitable disintegration time mensuration method and limit, and be incorporated into standard; 3. to insoluble medicine, should set up suitable dissolution determination method and limit; 4. other should meet general rule requirement under the tablet item.The characteristics of dispersible preparation are fast: 1. absorption is fast, bioavailability is high; 2. instructions of taking does not need water 3. intestinal is residual few, few side effects; 4. avoid the first pass effect of liver sausage.
The ageratum several formulations has had launch to sell at home, but in the practice, the weak point of these preparations is that preparation technology is outmoded, uses inconvenience, brings many troubles for the patient of old, children and dysphagia.The present invention adopts superfine communication technique and quick dispersion technology that HUOXIANG ZHENGQI ZHIJI is transformed, transformation process has overcome the difficulty that Chinese medicine preparation faces in the modified form process, particularly superfine communication technique and quick dispersion technology are applied to the difficulty that Chinese patent medicine faces, as moisture absorption, unstable, defectives such as technology is loaded down with trivial details, grope through screening and technology, under the constant situation of Chinese medicine preparation, prepared a kind of solid preparation similar to the ageratum effect with quick disintegration properties.
Summary of the invention:
The invention provides fast dispersion solid medicine of a kind of ageratum and preparation method thereof.
Preparation of the present invention has two kinds of prescriptions, and 13 flavor prescriptions and ten flavors are filled a prescription, and the preparation of the present invention that two kinds of prescriptions are made all is the fast dispersion solid medicine of ageratum of the present invention, wherein:
13 flavor prescriptions are as follows:
150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae (processed), 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae, 25 parts in Fructus Jujubae, 15 parts in Rhizoma Zingiberis Recens,
Ten flavor prescriptions are as follows:
195 parts of Rhizoma Atractylodis, 195 parts of Pericarpium Citri Reticulataes, 195 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 293 parts of the Radixs Angelicae Dahuricae, 293 parts in Poria, 293 parts of Pericarpium Arecae, 195 parts of Rhizoma Pinelliae, 24.4 parts of Radix Glycyrrhizae extractum, 1.95 parts of patchouli oils, 0.98 part of Folium perillae acutae oil,
More than form, part is a weight portion, as if being unit with the gram, can be made into the preparation of 50-1000 taking dose, as tablet, makes 1000, and each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be a unit with milli part also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, and for especial patient, the proportioning of can corresponding adjustment forming increases or reduce being no more than 100%.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Its adjuvant of quick dispersible preparation of the present invention is significant to the present invention, and adjuvant of the present invention is selected from disintegrating agent, adhesive, suspending (thickening) agent, fluidizer, correctives, rectifys toner.Wherein suspending (thickening) agent, strong toner add according to the needs of preparation, if preparation does not need, just do not add.
The used adjuvant of the present invention obtains through screening, wherein disintegrating agent is selected from, super carboxymethyl starch sodium (upright collapsing), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (polyvinylpolypyrrolidone, PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na, CCNa), low-substituted hydroxypropyl cellulose (LHPC) etc.For the less starch of swellbility, microcrystalline Cellulose etc. can guarantee the quick disintegrate of preparation (also can use under＜3min) the situation, but preferably swellbility greater than the disintegrating agent of 5ml/g.Adhesive is selected from polyvidone (PVP), for hyprolose sodium (HPMC); Suspending agent is selected from xanthan gum, Ka Baimu (CARBOMER), HPMC, melon glue.Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate.Correctives is selected from various essence, as Apis essence, green tea essence, Fructus Citri tangerinae essence, apple essence, flavoring pineapple essence, grape essence etc.Strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
The present invention also provides the preparation method of quick dispersible preparation of the present invention, this preparation method comprises, Chinese medicine pulverizing medicinal materials and/or extraction with above proportioning, ground product or extract obtain product after drying, through micronizing, obtain medicinal powder or the extract powder of particle diameter less than 75 μ m, this powder is as active constituents of medicine, mixed in the proper ratio with adjuvant through micronizing, make quick dispersible preparation of the present invention with the preparation technique of galenic pharmacy routine.Chinese medicine pulverizing medicinal materials described in this method can be according to traditional method as the method in " Ministry of Public Health standard for traditional Chinese medicines ": each composition is mixed in will filling a prescription earlier, is ground into fine powder, sieves, and mixing obtains.Described extraction can use decocting in water to extract, alcohol reflux, and ethanol percolation extracts, and the decocting in water precipitate with ethanol extracts, and any one in the multiple extracting method such as alcohol heavy extraction to boil water selected to use as required, and preferably decocting in water extracts.Decocting in water adopts and adds water 10-15 doubly, and decocting boils 2-3 time, and 1-3 hour for the first time, 1-3 hour for the second time, 1-3 hour for the third time, collecting decoction filtered, and concentrate drying obtains extract extractum.
In order to provide preparation good quick dispersive ability, need the granularity of strict control active constituents of medicine and adjuvant, just grain diameter is little.Therefore, the process characteristic of preparation of the present invention is, before the preparations shaping active constituents of medicine and adjuvant is all carried out micronization; Its objective is the wettability that increases the powder particle surface, promote the medicine stripping.The present invention adopts the method for micronizing, obtains Chinese medicine medicinal powder or the Chinese medicine extract of particle diameter less than 75 μ m, then with particle diameter quite or littler adjuvant is mixed evenly makes pharmaceutical preparation.For tablet, can adopt powder straight forming, wet granulation molding or dry granulation molding to prepare.
Superfine communication technique of the present invention, principal agent of the present invention and adjuvant are processed into particle diameter less than 75 μ m by existing superfine grinding method, are preferably less than 30 μ m, most preferably be micro powder granule less than 10 μ m, at present, micronization technology has two kinds of chemical method and Mechanical Method.Chemical synthesis can make micron order, submicron order even nano level powder body.The mechanical crushing method cost is low, output is big, be the preparation ultrafine powder main means, now large-scale application in commercial production.Micronizing can be divided into dry pulverization process and waterproof pulverization: different according to the principle that produces crush force in the crushing process, dry pulverization process has several forms such as air-flowing type, dither formula, screw (rod) mill formula, paddle type mill and Self-milling; Waterproof pulverization mainly is colloid mill and homogenizer.The present invention can obtain the product of particle diameter less than 75 μ m by above arbitrary method, preferably uses air-flow dry powder comminuting method.
Therefore, the disintegrating agent of the present invention in material principal agent of guaranteeing to use and adjuvant, adhesive, suspending (thickening) agent, fluidizer, correctives, to rectify toner etc. evenly mixed under all having less than the situation of 75 μ m particle diameters, the preparation solid preparation; Said preparation also has the high dispersive characteristic when being beneficial to absorption, can better absorb, and can take with solid form, also can add to take after making preparation be distributed in the liquid behind the liquid when taking, as use mixing in water for oral taking.
Quick dispersible preparation of the present invention, the part by weight of its principal agent and adjuvant is 100: 1～600, preferably 100: 50-400, more preferably 100: 100-200, wherein the part by weight of principal agent and disintegrating agent is 100: 10～500, preferably 100: 100-400, more preferably 100: 200-300.
Quick dispersible preparation of the present invention includes but not limited to fast disintegrating tablet as oral cavity disintegration tablet, and it can directly place the oral cavity, disperses by saliva, and disintegrate rapidly, no grittiness, good mouthfeel are beneficial to and swallow in the oral cavity.Also can be made into dispersible tablet, disperse fast in water, its dispersion liquid does not have grittiness, good mouthfeel, absorbs rapidly.
The weight proportion of principal agent of the present invention and adjuvant is preferably following proportioning:
100 parts of principal agents
Disintegrating agent, 10-500 part
Adhesive, 1-10 part
Suspending (thickening) agent, 0-10 part
Fluidizer, 0.5-5 part
Correctives, 0-2 part
Rectify toner.0-2 part
Wherein, preferred disintegrating agent is super carboxymethyl starch sodium (upright collapsing), carboxymethyl starch sodium (CMS-Na), microcrystalline Cellulose.Preferred adhesive is selected from polyvidone (PVP), for hyprolose sodium (HPMC).Preferred fluidizer is a differential silica gel.Preferred correctives is Apis essence, green tea essence.
Most preferred prescription composition of the present invention is listed in the embodiment of the invention.
Preparation of the present invention has the removing dampness of inducing sweat, regulate the flow of vital energy and in merit, can be used to treat diseases such as fever with chills, headache, stomachache, fullness in the chest are felt sick, vomiting and diarrhoea, preparation of the present invention comprises and is not limited to fast disintegrating tablet that can also prepare becomes oral cavity disintegration tablet; The latter can directly place the oral cavity, disperses by saliva, and disintegrate rapidly, no grittiness, good mouthfeel are beneficial to and swallow in the oral cavity.
Preparation method products therefrom of the present invention not only can be used to prepare tablet, can also combine other solid pharmaceutical preparation of preparation with suitable adjuvant, these preparations comprise and being not limited to: tablet (Sublingual tablet, chewable tablet, effervescent tablet, vaginal tablet, quick-release and slow-release controlled release tablet, enteric coatel tablets), suppository, capsule, pill, the agent of gas (powder) mist etc., and by conspicuous other application forms of the present invention.
The invention has the advantages that: the present invention is on the basis of the HUOXIANG ZHENGQI WAN prescription of determined curative effect and preparation process, adopt vanguard technology technology such as superfine communication technique, increased the dispersion of medical material effectively, and use quickly disintegrated adjuvant, make preparation have the feature of quick dispersion and very big degree of scatter simultaneously, thereby it is convenient that the more former dosage form of medicine is taken, by quick disintegrate (＜3min) reach the purpose that improves bioavailability.Can put into when dispersible tablet uses and take after water disperses, or directly place mouth, become liquid apace, and for this series products of ageratum, be particularly suitable for making preparation of the present invention, can solve as dysphagia person (especially old man, child), or the patient's medication problem under the special environment that can not obtain water, provide a great convenience.Wherein particle diameter less than the medicinal powder of 75 μ m or the extract powder adjuvant identical or littler with particle diameter mixed be key factor of the present invention.
Outside the requirement to corresponding drug standard of the quality evaluation of quickly disintegrated solid preparation and official preparation general rule, preparation disintegration time high spot reviews content, disintegration time＜3min.
Said preparation is principal agent (extract) with at least a disintegrating agent and meets water and form compatibility such as full-bodied swelling adjuvant and form, meet water disintegrate and form uniform viscosity suspension rapidly, it has taking convenience, absorption is fast, bioavailability is high and untoward reaction is few, the patient who is particularly suitable for old, children and dysphagia takes, and can characteristics such as produce with conventional tablet production technology and equipment, be a kind of good novel form.Therefore, the preparation Agastachel patchouli qi-righting fast dispersion solid preparation can provide new administration form for this traditional patent medicine of HUOXIANG ZHENGQI WAN, in abundant we's dosage form, can adapt to different patients' requirement, more helps bringing into play we's curative effect.
The specific embodiment:
Below by embodiment the present invention is elaborated.But should not be construed as the restriction to claim of the present invention of going up in all senses.
Embodiment 1
150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae (processed), 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae, 25 parts in Fructus Jujubae, 15 parts in Rhizoma Zingiberis Recens, more than 13 the flavor, get Herba Pogostemonis, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Magnoliae Officinalis, Rhizoma Zingiberis Recens is a solvent with 70% ethanol, the Rhizoma Pinelliae is a solvent with 45% ethanol, according to " the percolation dipping under Chinese pharmacopoeia fluid extract and the extractum item carried out percolation after 24 hours, collected the liquid of filtering, reclaim ethanol, it is the thick paste of 1.30～1.35 (20 ℃) that concentrating under reduced pressure becomes relative density; Get Folium Perillae and extract volatile oil, residue and Pericarpium Arecae, Fructus Jujubae decoct with water secondary, and 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into the thick paste that relative density is 1.30～1.35 (20 ℃); Get the Radix Angelicae Dahuricae, Poria, balloonflower powder and be broken into fine powder; Radix Glycyrrhizae partly is ground into fine powder, and part is made extractum; With above-mentioned each cream, powder mixing, micronizing is crossed 400 orders, adds Folium Perillae volatile oil, mixing, and per 100 parts of powder and adjuvant are evenly mixed, and the back tabletting of granulating is with Xin Feier coating material package clothing, promptly.See Table 1:
Table 1 preparation prescription and main evaluation result thereof
| The principal agent amount 1 | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other 2 | Disintegration time (min) |
| 100 | CMS-Na/50 | PVP/3 | Differential silica gel/1 | 1 | 1.5 |
Annotate: (1) is 100 parts with the principal agent amount, and other supplementary product consumption is a relative quantity, umber.(down together)
(2) other is the tender agent etc. of distinguishing the flavor of.(down together)
Embodiment 2
150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae (processed), 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae, 25 parts in Fructus Jujubae, 15 parts in Rhizoma Zingiberis Recens, more than 13 the flavor, be ground into fine powder, sieve, micronizing is crossed 400 orders, sieves mixing, per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 2:
Table 2 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Disintegration time (min) |
| 100 | CMS-Na/50 | PVP/2 | 2.5 |
Embodiment 3
150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae (processed), 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae, big 25 parts, 15 parts in Rhizoma Zingiberis Recens, more than 13 the flavor, be ground into fine powder, micronizing is crossed 300 orders, per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 3:
Table 3 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other | Disintegration time (min) |
| 100 | CMS-Na/60 | PVP/3 | Differential silica gel/1 | 1 | 2.6 |
Embodiment 4
160 parts of Rhizoma Atractylodis, 160 parts of Pericarpium Citri Reticulataes, 160 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 240 parts of the Radixs Angelicae Dahuricae, 240 parts in Poria, 240 parts of Pericarpium Arecae, 160 parts of Rhizoma Pinelliae, 20 parts of Radix Glycyrrhizae extractum, 1.6 parts (when solid unit was g, liquid unit was ml to patchouli oil; When solid unit was kg, liquid unit was 1; Down together), 0.8 part of Folium perillae acutae oil, more than ten the flavor, Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae are respectively according to the percolation under pharmacopeia fluid extract and the extractum item, make solvent with 60% ethanol, flood and carry out percolation after 24 hours, each collects the liquid 400ml that just filters first three kind, the first liquid 500ml that filters of a kind of collection in back, standby, continue percolation, collect the continuous liquid of filtering, incorporate in the liquid of just filtering after concentrating.After Poria adds water boil, 80 ℃ of warm macerating secondaries, 3 hours for the first time, 2 hours for the second time, extracting juice; The Rhizoma Pinelliae cold water soak was changed water once in per 8 hours, and bubble is to the saturating heart, and other adds 13.5 parts of Rhizoma Zingiberiss, decocts with water secondary, and 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocts with water 3 hours, and Radix Glycyrrhizae extractum is smashed the back decocting in water and melted; Merge above-mentioned decocting liquid, filter, filtrate is concentrated and dry, and dry thing is ground into fine powder, carries out micronizing, crosses 300 orders, and patchouli oil, Folium perillae acutae oil spray into mixing after dissolving with ethanol is an amount of then.Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 4:
Table 4 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other | Disintegration time (min) |
| 100 | CMS-Na/60 | PVP/3 | Differential silica gel/1 | 1 | 2.6 |
Embodiment 5
150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 100 parts of Pericarpium Citri Reticulataes, 100 parts of the Rhizoma Pinelliaes (processed with Rhizoma Zingiberis Recens), 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae, 25 parts in Fructus Jujubae, 15 parts in Rhizoma Zingiberis Recens, more than 13 flavors, the Rhizoma Pinelliae, the Rhizoma Atractylodis Macrocephalae are according to the percolation under pharmacopeia fluid extract and the extractum item, make solvent with 70% ethanol, carry out percolation, reclaim ethanol; Herba Pogostemonis, the Rhizoma Atractylodis Macrocephalae, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae and Folium Perillae distillating extracting oil; Six-elements such as medicinal residues and all the other Poria decoct with water three times, and collecting decoction filters, and filtrate is concentrated in right amount, merge with the liquid of filtering, and leave standstill, and filter, and reconcentration, drying are carried out micronizing, cross 300 orders, add above-mentioned volatile oil then.Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 5:
Table 5 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other | Disintegration time (min) |
| 100 | CMS-Na/60 | PVP/3 | Differential silica gel/1 | 1 | 2.6 |
Embodiment 6
80 parts of Rhizoma Atractylodis, 80 parts of Pericarpium Citri Reticulataes, 80 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 120 parts of the Radixs Angelicae Dahuricae, 120 parts in Poria, 120 parts of Pericarpium Arecae, 120 parts of Rhizoma Pinelliae, 10 parts of Radix Glycyrrhizae extractum, 0.8 part of patchouli oil, 0.4 part of Folium perillae acutae oil, more than ten the flavor, Cortex Magnoliae Officinalis was made the solvent reflux 1 hour with 60% ethanol, it is standby to get ethanol liquid; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae add the water distillation, collect distillate, and distillation back water liquid filters, and is standby; Pericarpium Arecae decocts with water 2 times, filters; After Poria added water boil, 80 ℃ of warm macerating secondaries filtered; To the saturating heart, other adds 6.8 parts of Rhizoma Zingiberiss to Rhizoma Pinelliae, decocts with water 2 times with blister.Merge above-mentioned filtrate, being concentrated into relative density is 1.10～1.20 (50 ℃), adds Radix Glycyrrhizae extractum, mixing adds 2 times of amount ethanol and makes precipitation, filters, filtrate and Cortex Magnoliae Officinalis ethanol extract merge, reclaim ethanol, filtrate concentrates and is dry, and dry thing is ground into fine powder, carry out micronizing, cross 300 orders, patchouli oil, Folium perillae acutae oil spray into mixing after dissolving with ethanol is an amount of then.Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 6:
Table 6 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Disintegration time (min) |
| 100 | CMS-Na/50 | PVP/4 | Differential silica gel/1 | 2.4 |
Embodiment 7
195 parts of Rhizoma Atractylodis, 195 parts of Pericarpium Citri Reticulataes, 195 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 293 parts of the Radixs Angelicae Dahuricae, 293 parts in Poria, 293 parts of Pericarpium Arecae, 195 parts of Rhizoma Pinelliae, 24.4 parts of Radix Glycyrrhizae extractum, 1.95 parts of patchouli oils, 0.98 part of Folium perillae acutae oil, more than ten the flavor, ethanol liquid is got in Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Angelicae Dahuricae ethanol extraction 2 times, and it is standby to be concentrated into clear paste; Poria, Pericarpium Arecae decoct with water 2 times, filter; The Rhizoma Pinelliae cold water soak was changed water once in per 8 hours, and bubble is to the saturating heart, and other adds 16.5 parts of Rhizoma Zingiberiss, decocts with water 2 times, filters.Merge above-mentioned filtrate, concentrate the back precipitate with ethanol, get supernatant concentration to clear paste; Add Radix Glycyrrhizae extractum, mixing, concentrated and dry, dry thing is ground into fine powder, carries out micronizing, crosses 300 orders, and patchouli oil, Folium perillae acutae oil spray into mixing after dissolving with ethanol is an amount of then.Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 7:
Table 7 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Disintegration time (min) |
| 100 | Upright collapsing/55 | PVP/3 | Differential silica gel/1 | 2.2 |
Claims (10)
1. an Agastachel patchouli qi-righting fast dispersion solid preparation is made by following Chinese medicinal raw materials: 150 parts of Herba Pogostemonis, 50 parts of Folium Perillaes, 50 parts of the Radixs Angelicae Dahuricae, 100 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 100 parts of Pericarpium Citri Reticulataes, 100 parts of Rhizoma Pinelliae (processed), 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 50 parts in Poria, 100 parts of Radix Platycodoniss, 100 parts in Radix Glycyrrhizae, 50 parts of Pericarpium Arecae, 25 parts in Fructus Jujubae, 15 parts in Rhizoma Zingiberis Recens;
Or 195 parts of Rhizoma Atractylodis, 195 parts of Pericarpium Citri Reticulataes, 195 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 293 parts of the Radixs Angelicae Dahuricae, 293 parts in Poria, 293 parts of Pericarpium Arecae, 195 parts of Rhizoma Pinelliae, 24.4 parts of Radix Glycyrrhizae extractum, 1.95 parts of patchouli oils, 0.98 part of Folium perillae acutae oil;
It is characterized in that, described fast dispersion solid medicine is after above-mentioned Chinese medicine is pulverized or extracted, carry out micronizing, obtain principal agent, this principal agent mixes with the adjuvant that is selected from disintegrating agent, adhesive, suspending agent, fluidizer, correctives, strong toner, make preparation with the galenic pharmacy routine techniques, wherein the granularity of principal agent that all uses and adjuvant is all less than 75 μ m particle diameters.
2. the fast dispersion solid medicine of claim 1 is characterized in that, wherein the granularity of principal agent that all uses and adjuvant is all less than 30 μ m particle diameters.
3. the fast dispersion solid medicine of claim 1 is characterized in that, wherein the granularity of principal agent that all uses and adjuvant is all less than 10 μ m particle diameters.
4. the fast dispersion solid medicine of claim 1, it is characterized in that, wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone, for hyprolose sodium; Suspending agent is selected from xanthan gum, Ka Baimu, HPMC, melon glue; Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate; Correctives is selected from various essence, and strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
5. the fast dispersion solid medicine of claim 1 is characterized in that, is tablet, and it is composed as follows:
100 parts of principal agents
Disintegrating agent, 10-500 part
Adhesive, 1-10 part
Suspending agent, 0-10 part
Fluidizer, 0.5-5 part
Correctives, 0-2 part
6. the preparation method of the described fast dispersion solid medicine of claim 1 is characterized in that, the process following steps:
(1) get respectively distinguish the flavor of medical material or decoction pieces according to the Chinese medicine preparation in the claim 1, after pulverizing or extracting, carry out the micronizing of granularity less than 75 μ m particle diameters, standby;
(2) resulting micropowders identical or littler with particle diameter is selected from following adjuvant: disintegrating agent, adhesive, suspending agent, fluidizer, correctives or strong toner mix homogeneously are prepared into preparation.
7. preparation method according to claim 6, it is characterized in that, wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone, for hyprolose sodium; Suspending agent is selected from xanthan gum, Ka Baimu, HPMC, melon glue; Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate; Correctives is selected from various essence, and strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
8. according to the described preparation method of claim 6, it is characterized in that the ratio of principal agent and adjuvant is 100: 1～600 in the preparation.
9. according to the described preparation method of claim 6, it is characterized in that the ratio of principal agent and disintegrating agent is 100: 10～500 in the preparation.
10. according to the described preparation method of claim 6, it is characterized in that described preparation is a tablet, adopt powder straight forming, wet granulation molding or dry granulation molding.
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Address after: 1266 No. 330052 Nanchang Huiren Jiangxi economic and Technological Development Zone Avenue. Patentee after: JIANGXI HUIREN PHARMACEUTICAL CO.,LTD. Address before: 330043 1189 Yingbin Avenue, Nanchang, Jiangxi Patentee before: Jiangxi Huiren Pharmaceutical Co.,Ltd. |
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